United States securities and exchange commission logo
April 20, 2021
Stephan Jackman
Chief Executive Officer
Alzamend Neuro, Inc.
3802 Spectrum Boulevard
Suite 112C
Tampa, Florida 33612
Re: Alzamend Neuro,
Inc.
Amendment No. 1 to
Draft Registration Statement on Form S-1
Submitted April 2,
2021
CIK No. 0001677077
Dear Mr. Jackman:
We have reviewed your amended draft registration statement and
have the following
comments. In some of our comments, we may ask you to provide us with
information so we
may better understand your disclosure.
Please respond to this letter by providing the requested
information and either submitting
an amended draft registration statement or publicly filing your
registration statement on
EDGAR. If you do not believe our comments apply to your facts and
circumstances or do not
believe an amendment is appropriate, please tell us why in your
response.
After reviewing the information you provide in response to these
comments and your
amended draft registration statement or filed registration statement, we
may have additional
comments.
Amendment No. 1 to Draft Registration Statement
Our Company, page 1
1. We reissue comment 2.
Revise to clarify that you are a pre-clinical stage company.
Our Product Candidates, page 1
2. Refer to comment 3. You
revised the document to refer to AL001 not as your lead
product candidate,
which was appropriate, but as the "patented solution" that you "will
first move to
commercialization." As "solution" implies efficacy and "commercialization"
implies FDA approval,
please delete these and similar references for the reasons cited in
comment 3.
Stephan Jackman
Alzamend Neuro, Inc.
April 20, 2021
Page 2
3. We refer to your statements on page 2 that a product candidate could
be designated as a
"breakthrough therapy" or qualify for expedited development. As
requested by prior
comment 5, please balance your discussion by disclosing that you have
not received these
designations and expand your disclosure to explain that this
designation, if received, does
not increase the likelihood that your product candidate will receive
approval.
4. We note the FDA correspondence you provided in response to comment 7.
Tell us how
you determined from the FDA's response that your proposed test
parameters were
reasonable to support human clinical trials, as you disclose on page
2.
Dilution, page 41
5. Please explain how you calculated the historical net tangible book
value as of January 31,
2021 of $802,007 as that appears to be your amount of Total Assets.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Plan of Operation, page 44
6. We note your response to comment 17. Disclose the delay in results
from the study and
the reasons for the delay.
Impact of Coronavirus on Our Operations, page 53
7. We note your response to comments 20 and 21. Revise this section
and/or your disclosure
in the Facilities section on page 73 to clarify whether or to what
extent remote work
necessitated by coronavirus restrictions has negatively impacted your
efficiency.
Business
Our Proprietary Technology, page 57
8. We note the revised disclosure reporting results of your preclinical
studies. Revise to
briefly disclose the material study data supporting these conclusions,
including for
example, the numbers of subjects and length of study. Quantify your
descriptions of
results, such as "improved cognitive function," "reduced depression,"
and "superior
protection" and clarify whether the amounts were statistically
significant.
Description of Capital Stock, page 91
9. We note your response to comment 33 and the revised disclosure on page
93 reflecting the
content of your bylaws in the present tense. As you have included as
exhibits both your
prior bylaws (Exhibit 3.2), and now contain your Amended and Restated
Bylaws (Exhibit
FirstName LastNameStephan Jackman
3.3), revise the Choice of Forum section on page 93 to clarify that the
choice of forum
Comapany NameAlzamend
provision is found in Neuro, Inc.
your "Amended and Restated Bylaws." Tell us why
you have
retained
April 20, your 2prior bylaws as an exhibit if they are no longer in
effect.
2021 Page
FirstName LastName
Stephan Jackman
FirstName LastNameStephan Jackman
Alzamend Neuro, Inc.
Comapany
April NameAlzamend Neuro, Inc.
20, 2021
April 320, 2021 Page 3
Page
FirstName LastName
You may contact Nudrat Salik at (202) 551-3692 or Vanessa Robertson at
(202) 551-
3649 if you have questions regarding comments on the financial statements and
related
matters. Please contact Abby Adams at (202) 551-6902 or Tim Buchmiller at (202)
551-
3635 with any other questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Spencer G. Feldman, Esq.